Howard Mann's reply to my article1 contributes to the discussion about IRB “shopping,” and his ideas are very intriguing. His argument in favour of public access is important, but I wonder if the system should be fully publicly available.
Whatever mechanism Canada adopts in creating a centralized REB system, I believe it must be based on promotion of the public's interest, including the protection of our country's involvement in international pharmaceutical trials. Our national regulatory authority, Health Canada's Therapeutic Products Directorate, will need to determine if a trial registry with mandatory public disclosure rules, as opposed to more limited mandatory disclosures among REBs, will negatively influence decisions to proceed with trials. Issues of intellectual property will likely be raised and may reduce Canadian trial activity, thereby influencing the number and kinds of pharmaceutical drugs or devices available in the longer term.
If mandatory public disclosure would reduce Canada's involvement in trials, then we may want to concentrate our efforts on other mechanisms to protect the public interest with respect to the conduct of clinical trials.
That being said, if the FDA were to legislate the system described by Mann, smaller countries with less market share potential would find it easier to adopt a similar system; such an action by the FDA would probably influence sponsors' acceptance of that regulatory practice. Given that international pharmaceutical trials often involve both the US and Canada, sponsors would likely accept harmonized regulatory practices with respect to public disclosure.
Lorraine E. Ferris Associate Professor Department of Public Health Sciences Faculty of Medicine University of Toronto Toronto, Ont.
Reference
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